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The goal of this clinical trial is to learn if fecal microbiota transplantation (FMT) works to treat alopecia areata in adults. It will also learn about the safety of FMT. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT group | Experimental | Interventional group |
|
| Placebo group | Placebo Comparator | This group will recieve placebo capsules or saline via colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbial Transplant Enema | Other | Patients with alopecia areata will recieve FMT or in the 3 capsules for three consecutive days or FMT via colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in hair growth- Severity of Alopecia Tool | The primary success will be a statistically significant difference in hair regrowth between the Fecal Microbiota transplantation (FMT) group and placebo group at weeks 24 and 48, assessed as a binary endpoint (regrowth yes/no) and supported by changes in SALT (Severity of Alopecia Tool) score as a standardized measurement used to quantify scalp hair loss in patients with alopecia areata. The scale ranges from 0 (no hair loss) to 100 (complete scalp hair loss). A clinically meaningful reduction in SALT score (≥50% improvement from baseline) will be considered a strong indicator of therapeutic efficacy. | From enrollment to the end of treatment at 48 weeks |
| Changes in hair growth- Alopecia Areata Investigator Global Assessment | The primary success will be a statistically significant difference in hair regrowth between the Fecal Microbiota transplantation (FMT) group and placebo group at weeks 24 and 48, assessed as a binary endpoint (regrowth yes/no) and supported by changes in Alopecia Areata Investigator Global Assessment (AA-IGA) to measure five clinically meaningful gradations of alopecia areata scalp-hair loss that reflects patients' and clinicians' perspectives and expectations of treatment success in alopecia areata treatment studies. The AA-IGA score is based on the patient's SALT score. The scale is numbered from 0, which corresponds to 0% of hair loss (ie, SALT 0), indicating no hair loss, to 4, which corresponds to 95-100% of hair loss (ie, SALT 95-100), indicating very severe hair loss. | From enrollment to the end of treatment at 48 weeks |
| Changes in hair growth- The Alopecia Areata Scale | The primary success will be a statistically significant difference in hair regrowth between the Fecal Microbiota transplantation (FMT) group and placebo group at weeks 24 and 48, assessed as a binary endpoint (regrowth yes/no) and supported by changes in The Alopecia Areata Scale (AASc) in wich primary criterion is Severity of scalp hair loss: mild 20% or less, moderate 21-49%, severe 50-100% scalp hair loss. Secondary criteria: is any is present, increase severity rating by one level: noticeable involvement of eyebrows or eyelashes; inadequate response after at least 6 months of treatment; negative impact on psychosocial functioning resulting from AA; diffuse (multifocal) positive hait pull test consistent with pidly progressive alopecia areata. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tea Rosovic, Dermatovenerology specialist | Contact | +00385913737237 | tearosovic@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polyclinic GrandMed | Opatija | Croatia |
IPD used in the results publication
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
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|
| Placebo | Other | Patients will recieve three capsules with inert material or saline via colonoscopy |
|
| From enrollment to the end of treatment at 48 weeks |
| Fecal microbiota transplantation modulation of the gut and skin microbiota | The primary objective of this proposal is to test the hypothesis that fecal microbiota transplantation (FMT) induces beneficial modulation of the gut and skin microbiota, leading to immunoregulatory effects in patients with alopecia areata (AA). Characterize baseline skin, and colonic mucosal microbiota composition in patients with AA using 16S rRNA sequencing of skin and colon musosa biopsy specimens and assess changes following FMT. | From enrollment to the end of treatment at 48 weeks |
| Change in T cell subsets from Baseline to 48 weeks | Before and after Fecal microbiota transplantation patient will be taken 60-80 ml of peripheral blood for:
| From enrollment to the end of treatment at 48 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |